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Ultradent Products, Inc. FDA Recalls
5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.Class IIJan 28, 2026Composite polisher cups may crumble and break apart easily, |
| Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- SofClass IIAug 2, 2024Due to a manufacturing issue, red particulates present in th |
| Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: Class IIAug 2, 2024Due to a manufacturing issue, red particulates present in th |
| Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A PClass IIAug 2, 2024Due to a manufacturing issue, red particulates present in th |
| Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE PrimeClass IIJun 1, 2022SE primer may be missing some or all of the resin portion of |